FDA Device recall Z-2702-2026
5008X Blood Tubing Set, 24 units per case
- FDA Device
- Class II
- ongoing
- Published 2026-07-15
On 2026-07-15 the FDA classified a Class II recall of 5008X Blood Tubing Set, 24 units per case by Fresenius Medical Care Holdings, citing potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2702-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-11 |
| Published | 2026-07-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 3. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 4. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
Reason
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Identifiers
| code_info | Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6; UDI-DI: 00840861102556; Lot Number: 26BR01177.…Sets manufactured after February 26, 2026 1. Model Number: 03-5110-6; UDI-DI: 00840861102556; Lot Number: 26BR01177. 2. Model Number: 03-5300-3; UDI-DI: 00840861102518; Lot Numbers: 26BR01184, 26BR01202, 26CR01025, 26CR01039, 26CR01803, 26BR01185, 26BR01214, 26CR01026, 26CR01040, 26CR01804, 26BR01188, 26BR01215, 26CR01027, 26CR01041, 26DR01134, 26BR01189, 26BR01805, 26CR01029, 26CR01043, 26BR01201, 26CR01003, 26CR01034, 26CR01800. 3. Model Number: 03-5300-3C; UDI-DI: 00840861102532; Lot Numbers: 26CR01018, 26CR01020, 26DR01129, 26DR01150, 26CR01019, 26CR01021, 26DR01130, 26DR01151. 4. Model Number: 03-5350-8; UDI-DI: 00840861102525; Lot Numbers: 26CR01017, 26DR01077, 26DR01079, 26DR01080. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2702-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.